Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Altrix Temperature Management Wraps

K-Number: K171149 · 2017-07-18

ApplicantStryker Medical
Decision Date2017-07-18
Product CodeDWJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Altrix Temperature Management Wraps is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Medical. It received FDA 510(k) clearance on 2017-07-18 under 510(k) number K171149. The device is classified under product code DWJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Altrix Temperature Management Wraps?

Altrix Temperature Management Wraps is a medical device that received FDA 510(k) clearance on 2017-07-18. The listed applicant is Stryker Medical. The 510(k) number is K171149.

When did Altrix Temperature Management Wraps receive FDA 510(k) clearance?

Altrix Temperature Management Wraps received FDA 510(k) clearance on 2017-07-18, under 510(k) number K171149.

Who is the listed applicant for Altrix Temperature Management Wraps?

The FDA 510(k) record lists Stryker Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Altrix Temperature Management Wraps?

The FDA product code for Altrix Temperature Management Wraps is DWJ.

Other records listing Stryker Medical as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K222818Xpedition ™ Powered Stair Chair (625700000000)K180834Altrix Precision Temperature Management SystemK152266Altrix Precision Temperature Management System

Related Devices (Code: DWJ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261437Mistral-Air® Warming SystemThe Surgical Company International B.V., doing business as TSC LifeK260278ThermAffyx(TM) Patient Safety SystemStihler Electronic GmbHK260903Hot Pink Pad Warming SystemXodus Medical, Inc.K252861Warming SystemHangzhou Tappa Medical Technology Co., Ltd.K251974Arctic Sun Temperature Management System (Model 5000)Medivance, Inc.K242964Celsi WarmerHadleigh Health Technologies

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑